Colorectal cancer, colorectal carcinoma, pancreas carcinoma
Conditions
Interventions
None listed
Sponsors
Catharina Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Pathologically confirmed malignancy for which treatment with irinotecan is indicated at a dosing regimen of >= 180 mg/m2 in 2- or 3-weekly treatment schedules. • Patients who will start with their first cycle of treatment with chemotherapy • Age >= 18 years • Able and willing to give written informed consent • Patient is able to temporarily store fecal samples in their freezer • WHO performance status 0-2 • Minimal acceptable safety laboratory values defined as: o ANC of >= 1.5 x 109 /L o Platelet count of >= 100 x 109 /L o Hepatic function as defined by serum bilirubin = 50 ml/min or creatinine
Exclusion criteria
Exclusion criteria: • Patients with recently performed intestinal surgery including colectomy • Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient*s safety • Patients with either a ileostomy, ascending colostomy or transverse colostomy • Patients unable or unwilling to stop the use of (over the counter) medication or (herbal) supplements which can interact with irinotecan (e.g. by induction of inhibition of CYP3A4) • Patients with an inability to undergo additional blood sampling. • Patients with an inability to collect stool samples at home (e.g. disabilities or incontinency). • Patients with an inability to read and understand the informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to describe the pharmacokinetics of irinotecan, SN-38 and SN-38G in plasma and in theintestines by using a pharmacokinetic compartment model | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the beta-glucuronidase activity in fecal samples by an enzym-activity assay | — |
Countries
Netherlands
Contacts
Public ContactT.M.M. Böhm
Catharina Ziekenhuis
Outcome results
None listed